BaSICS Trial

JAMA

August 10, 2021

Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients.

Summarized by: 

Mazen Kherallah

What was the research question?

  • Does the use of a balanced solution (Plasma-Lyte 148) reduce 90-day mortality compared to saline solution (0.9% sodium chloride) in critically ill patients?


How did they do it?

  • A double-blind, factorial, randomized clinical trial conducted at 75 ICUs in Brazil.

  • 11052 patients who were critically ill and had at least one risk factor for worse outcomes (had least 1 fluid expansion and expected to remain in the ICU for > 24 hours) and had at one risk factor for acute kidney injury (>65 years, hypotension, sepsis, >12 hours of HFNC, NIV, MV, oliguria >3 hours, serum creatinine >1.2 mg/dL in women or >1.4 mg/dL in men, cirrhosis or acute liver failure) were randomized with 1:1 assignment to receive either a balanced solution (Plasma-Lyte 148 (n = 5522) or 0.9% saline solution (n = 5530) for all intravenous fluids.

  • Each group was also randomized to 2 different infusion rate 333 mL/hour vs 999 mL/hour in a 2X2 factorial design.

  • The primary outcome was 90-day mortality.


What did they find?

  • 90-day mortality was not significantly different between the balanced fluid group and the saline group (26.4% vs. 27.2%, HR, 0.97 [95% CI, 0.90-1.05]; P = .47).

  • Among the secondary outcome measures, the incidence of AKI with need for RRT within 90 days per 1000 patient days was not statistically different between the two groups (27.8% vs. 28.9%, OR 0.95 [95% CI 0.86-1.04]).

  • Sub-group analyses revealed a significant difference with a higher mortality in the balanced fluid group in patients with traumatic brain injury (31.3% vs. 21.1% HR, 1.48 [95% CI, 1.04-2.12]; P = .02).


Are there any limitations?

  • About 45% of participants received more than 1 liter of IV fluid which could have impacted the study results.

  • Mostly lower acuity ICU patients (median APACHE II was 12) and planned surgical admissions represented 48.4% of all patients which impacted the predicted mortality rate (actual 27.2 vs expected 35%). Thus, the study is underpowered with increase potential for type-II error.


What does it mean?

  • There was no difference in 90-day mortality among critically ill patients requiring fluid challenges between a balanced solution and normal saline.

  • Use of saline is safe in ICU patients.

  • Avoid using balanced fluid in traumatic brain injury patients.

BaSICS Trial